Enfuvirtide - EPARs for authorised medicinal products for human use - Fuzeon

FICHA FARMACOLÓGICA de Enfuvirtide . Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. MAYO 09, 2010.-

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EPARs for authorised medicinal products for human use - Fuzeon

Active Substance
Enfuvirtide
International Nonproprietary Name or Common Name
Enfuvirtide
Pharmaco-therapeutic Group
Other antivirals
ATC Coe
J05A X07

Therapeutic Indication:
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.

In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.

Date of issue of Marketing Authorisation valid throughout the European Union
27 May 2003

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use